510(k) · Cleared
ClearedSol-M Insulin Syringe, Sol-M TB Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sol-Millennium Medical, Inc. · FMF Syringe, Piston
Cleared on Jun 17, 2016 as substantially equivalent to K112057 (Shanghai Kindly Enterprise Dev. Group Co.,, 2011) after a 190-day review. Its family tree reaches back 6 generations to 1993. 5 later devices descend from it.
- Decided
- Jun 17, 2016
- Review
- 190 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931367 (1993). 22 ancestors in all, the oldest K822083 (1982). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 5 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 4 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 3 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 2 generations backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- 1 generation backK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- This deviceK153537 Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK211242 Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK213560 Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK231792 VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK250192 Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220713 Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesPromisemed Hangzhou Meditech Co., Ltd. · 2021 · cites it directly3descendants
- K213560Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022 · 2 generations on2descendants
- K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd. · 2023 · 3 generations on1descendant
- K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd. · 2025 · 4 generations on0descendants
- K220713Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −5 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −4 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −3 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −2 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| −1 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| 0 (this device) | K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | Sol-Millennium Medical, Inc. | 2016 | — |
| +1 | K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +2 | K213560 | Verifine Safety Syringe with Fixed Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022 | — |
| +3 | K231792 | VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| +4 | K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025 | — |
| +1 | K220713 | Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112057 | KDL Syringes and NeedleSummary page 5…Reason for 510(k): New device C. Predicate Device: KDL Syringes and Needles Predicate 510(k) #: K112057 Predicate product code: FMF Reference Devices: Sol-Guard Insulin and Tuberculin… | 2011 |
| † | K132681 | Sol-Guard Insulin and Tuberculin Safety Syringe | 2014 |
| † | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock… | 2009 |
| † | K101359 | Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K211242 (Promisemed Hangzhou Meditech Co., Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K112057.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153537: Sol-M Insulin Syringe, Sol-M TB Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153537
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026